Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3520](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3520) → HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer # HSX · Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer _Orthopedic · 21 CFR 888.3520 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX ## Overview - **Product Code:** HSX - **Device Name:** Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer - **Regulation:** [21 CFR 888.3520](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3520) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027). ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 114) Showing 20 most recent of 114 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260796](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K260796.md) | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | Apr 2, 2026 | SESE | | [K251771](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K251771.md) | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | Dec 16, 2025 | SESE | | [K251834](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K251834.md) | Persona Partial Knee | Zimmer Biomet | Aug 15, 2025 | SESE | | [K251618](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K251618.md) | MOTO Partial Knee System Extension | Medacta International S.A. | Jul 24, 2025 | SESE | | [K251453](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K251453.md) | Arthrex iBalance Partial Knee System | Arthrex, Inc. | Jul 1, 2025 | SESE | | [K241260](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K241260.md) | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | Dec 6, 2024 | SESE | | [K242711](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K242711.md) | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | Oct 30, 2024 | SESE | | [K242746](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K242746.md) | OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics | Oct 7, 2024 | SESE | | [K232114](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K232114.md) | TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. | Apr 4, 2024 | SESE | | [K221292](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K221292.md) | Uni Knee Resurfacing System | Overture Resurfacing, Inc. | Mar 10, 2023 | SESE | | [K212870](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K212870.md) | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | Jun 16, 2022 | SESE | | [K220930](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K220930.md) | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | Jun 2, 2022 | SESE | | [K211471](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K211471.md) | Balanced Knee System Uni | Ortho Development Corporation | Dec 16, 2021 | SESE | | [K213071](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K213071.md) | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | Nov 16, 2021 | SESE | | [K212307](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K212307.md) | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | Oct 12, 2021 | SESE | | [K211512](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K211512.md) | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | Sep 16, 2021 | SESE | | [K211895](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K211895.md) | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | Aug 20, 2021 | SESE | | [K203697](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K203697.md) | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | Mar 12, 2021 | SESE | | [K203341](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K203341.md) | ACS LD Uni FB Knee System | Implantcast GmbH | Jan 8, 2021 | SESE | | [K203099](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX/K203099.md) | Triathlon PKR System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | Oct 27, 2020 | SESE | ## Top Applicants - Smith & Nephew, Inc. — 13 clearances - Zimmer, Inc. — 9 clearances - Conformis, Inc. — 8 clearances - Bodycad Laboratories, Inc. — 7 clearances - Depuy, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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